cdsco initiatives & targets for website 13-7-2012!17!07-2012

8/11/2019 CDSCO Initiatives & Targets for Website 13-7-2012!17!07-2012

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Initiatives, Achievements and Targets

Central Drugs Standard Control Organization

2001 - 2020)

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug

Authority for discharging functions assigned to the Central Government under the

Drugs and Cosmetics Act.

CDSCO has six zonal offices, four sub-zonal offices, 11 port offices and six

laboratories under its control.

CDSCO North Zone (Ghaziabad)

.

CDSCO West Zone (Mumbai)

CDSCO South Zone (Chennai)

CDSCO East Zone (Kolkata)

CDSCO – Geographical Location Zonal /Sub Zonal Offices

Port Offices/Airports : 11Laboratories : 6

29 States

6 Union Territories

CDSCO Zone (Ahmadabad)

CDSCO Zone (Hyderabad)

•Proposed Sub Zonal Offices (2) :•Guwahati, Indore,

CDSCO Sub Zone (Bangaluru)

CDSCO Sub Zone (Chandigarh)

CDSCO Sub Zone (Jammu) and (Goa)

Major functions of CDSCO:

1. Regulatory control over the import of drugs, approval of new drugs and

clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs

Technical Advisory Board (DTAB), approval of certain licences as Central

Licence Approving Authority is exercised by the CDSCO hqrs.



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2. Zonal offices carry out joint inspections and coordinate with the State Drugs

Controllers under their jurisdiction.

3. Quality control of drugs imported is exercised by the port offices.

4. Drugs testing laboratories test drug samples forwarded to them for test.

Achievements and Initiatives:

2000-2012

Year Achievements/ Initiatives

2001 Requirements for GMP amended to ensure quality of drugs.

2002 Notified In-vitro diagnostic kits (HIV, HBsAg and HCV) as Drugs toregulate its Import, Manufacture, sale and distribution.

Setup of New Sub-Zonal office of CDSCO at Ahmadabad

Functioning of Regional Drugs Testing Laboratory at Guahwati

Release of Indian Pharmacopoeia Addendum 2002 and the

Veterinary products supplement in 2002

2003 Monitoring the quality of imported drugs by making mandatory forRegistration of Manufacturing site and products before import.

Prepared a list of National List of Essential Medicines (NLEM).

Publication of Transfusion Medicine, Technical Manual for BloodBank (second edition)

2004 National Regulatory Authority assessment in respect of Regulatory

Control over vaccines manufactured in the country.

Launched National Pharmacovigillance Program.

2005 Amended Schedule Y- Requirements and guidelines forpermission to import and/or manufacture of New Drugs for Sale orto undertake Clinical Trials.

Good Clinical Practices (GCP) Guidelines for Clinical Trials in

India.

Notified 10 medical devices as Drugs to regulate its Import,



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Manufacture, sale and distribution.

Launch of CDSCO official website.

Publication (Second Edition) of Drugs and Cosmetic Act and

Rules.

Compilation of all Drugs Consultative Committee (DCC) and Drugs

Technical Advisory Board (DTAB) minutes.

Notified recombinant drug products and Medical Devices (10

devices) under Central Licensing Approving Authority Scheme.

Release of Indian Pharmacopoeia Addendum 2005

2000-

2005

Enhanced Capacity of drug testing facilities at both state and

central drugs testing laboratories under Centrally SponsoredScheme.

Conducted various Consumer Awareness Program on RationalUse of Medicines.

Major final notification issued pertain to the enhancement ofvalidity period of manufacturing and sale licences from 2 years to5 years and upward revision of licence fees and to curb misuse of

Oxytocin injection, it has now been made mandatory to pack it in asingle unit blister pack only.

To declare National Institute of Biological, Noida as an appellatelaboratory for testing blood grouping sera and certain diagnostickits.

The state licensing authorities seek approval for DCG(I) for newdrugs before licensing them for manufacture.

Kandla Port made as port of entry for import of drugs into thecountry.

Computerization of state drugs control organisations and CDSCOby providing computer hardware under Centrally SponsoredScheme.

Imparted Training to State and Central Drug Control Officials

through Drugs Inspectors Training Scheme (DITS).



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Strengthening of the regulatory infrastructure by enhancingcapacity in existing drug laboratories at the sates and central levelthrough infrastructure and equipment strengthening and training ofpersonnel to upgrade their skill under Capacity Building Project.

2006 Set up of Regional Drugs Testing Laboratory at Chandigarh

2007 Constructed new independent building for CDSCO under CapacityBuilding Project.

2000 -2007

Drugs Banned-

1. Fixed Dose combination of corticosteroid with any other drug forinternal use except for preparations meant for meter doseInhalers and dry powder inhalers.

2. Fixed Dose combination of Rifampicin, Isoniazid andPyrazinamide, except those which provide daily adult dose givenbelow:-

3. Fixed Dose combination of Salbutamol or any other drug havingprimarily bronchodilatory activity with centrally acting anti-tussiveand/ or antihistamine.

4. Fixed dose combination of Metoclopramide with other drugsexcept combination of Metoclopramide with Aspirin/ Paracetamol.

5. Fixed dose combination of Diazepam and DiphenhydramineHydrochloride.

6. The Drug Astemizole and Terfinadine have been prohibited.

Drugs Minimum Maximum

Rifampicin 450 mg. 600 mg.

Isoniazid 300 mg. 400 mg.

Pyrazinamide 1000 mg. 1500 mg.

2008 June 2012:

NRA assessment:

WHO in the year 2007 had conducted a National Regulatory Authority (NRA)assessment in respect of Regulatory Control over vaccines manufactured in the



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country. The WHO was not satisfied and this resulted in disqualification of NRA in

January 2008. CDSCO took the initiatives beginning from March 2008 for

strengthening the biological division and imparting necessary skills, under

capacity building, with the cooperation of Health Canada. A document system for

quality assurance was developed and Common Technical Document (CTD)format for filing the applications in accordance to ICH guidelines was introduced.

In the subsequent NRA assessment in April 2009, Guidelines, Standard Operative

Procedures and checklist for all critical functions of dossier review etc introduced

in the system by CDSCO were reviewed by WHO, CDSCO qualified the NRA

assessment with 100% scores in all the critical indicators.

Table- I

Strengthening of CDSCO:

CDSCO was facing an acute manpower crunch in 2008. Since the work load was

increasing at an average of 20% to 25%, the Ministry of Health and Family Welfare

sanctioned 216 additional new posts in the year 2008-2009. With this sanctioned

man power strength of CDSCO has risen to 327. The Ministry of Health and Family



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Welfare appreciating the need of further manpower, sanctioned engagement of

additional 234 contractual staff to assist the CDSCO in discharging its duties.

Further the proposal to create 1195 additional posts is under consideration of the

Government to strengthen CDSCO.

Sanctioned Posts

as on 2007

Sanctioned Posts

as on 2009

Proposed additional Posts

in 12th Five Year Plan

111 327 1195

Present position of sanctioned and vacant post is placed in Table-I

Expansion of infrastructure:

During this period:

Sub zonal offices at Hyderabad and Ahmadabad were upgraded tozonal offices

New Sub Zonal offices at Bangalore, Jammu, Chandigarh and Goa areset up.

New Building of Zonal FDA Bhawan at Mumbai was inaugurated byUnion Health Minister on 11th Jan, 2010

New CDSCO Bhawan at Hyderabad was inaugurated by Union Health

Minister on 5th Feb, 2011.

Testing capacities of the existing Central Drugs Testing Laboratories atKolkata, Mumbai, Chennai and Kasuali and Regional Drugs TestingLaboratory Guwahati were enhanced.

A new laboratory was set up at Chandigarh and Hyderabad.

Initiatives at International forum:



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During this period CDSCO collaborated with US FDA, Health Canada,and Brazil and South Africa regulatory authorities.

Collaborative workshops were held with US FDA on the subjects ofclinical trial inspections and Regulation of Medical Devices.

Amendments in the Regulatory Provisions under the Drugs andCosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945

Drugs and Cosmetics Act, 1940 was amended under Drugs and Cosmetics(Amendment) Act, 2008 and it came into force on 10th August 2009. Under this

Act stringent penalties for manufacture of spurious and adulterated drugs wereprovided. Certain offences relating to spurious and adulterated drugs weremade cognizable and non-bailable.

Setting up of designated special Courts for trial of offences relating to the Drugsand Cosmetics Act were also provided. 14 states set up designated courts.

Guidelines for taking action in the cases of spurious and substandard drugs inthe light of enhanced penalties under the amended Act were prepared andforwarded to the State Drugs Control Authorities. These guidelines were alsoforwarded by the Ministry of Health and Family Welfare to the State

Governments for compliance.

Drugs and Cosmetics Rules, 1945 were constantly updated to make theprovisions responsive to the present day needs of the society. The number ofnotification issued during these periods are as under:

S. No. Year Draft Rules Final

Notification

Notification for

Banning of drugs

1 2008 2 2 1

2 2009 5 10 2

3 2010 4 3 1

4 2011 2 2 4

The salient amendments are as under:

1. Good Laboratories Practices were notified under notification GSR 780(E) dated

10.11.2008 and became operative since 1.11.2010.



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2. A system of registration of import of cosmetics has been introduced under the

Gazette notification GSR 426(E) dated 19.05.2010. The registration of cosmetics

will become mandatory from 1.04.2012.

Banning of Drugs:

The drugs about which the Central Government is satisfied that their use is likelyto involve risk to human being and animals are prohibited under Section 26A ofthe Drugs and Cosmetics Act. The following drugs have been banned during theperiod 2008 - 2011.

2008

Diclofenac and its formulations for animal use

2009

Rimonabant

2010

Rosiglitazone

2011

1. Nimesulide and its formulations for human use in children below 12 yearsof age,

2. Cisapride,

3. Phenylpropanolamine,

4. Human Placental Extract formulation excepts its injectable for pelvicinflammatory diseases and topical application for wound healing

5. Sibutramine;

6. R-Sibutramine

7. Gatifloxacin formulation for systemic use in human by any route includingoral and injectable;

8. Tegaserod.

9. Letrozole for induction of ovulation in anovulatory infertility was suspended.

Initiatives in Enforcement of the Drugs and Cosmetics Rules:



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a. More than 100 import licenses of drugs were cancelled in 2009 followingcancellation of registration certificates due to submission of non authenticGMP certificates.

b. Surveillance by the CDSCO officers at the ports in 2008 resulted in

detection of certain cases of import of drugs from unregistered sources ofdoubtful quality. The cases were handed over to the CBI for investigationand taking further action.

c. Implementation of “whistle blower scheme” to motivate the public andprovide information to the regulators on movement of spurious drugs.

d. The surprise investigation/Inspection of Whole Sale/Retail/Hospitalpremises for the availability of prohibited drugs (Gatifloxacin, Tegaserodand Rosiglitazone) was carried out on dated 15 th June 2011 at NationalCapital Region New Delhi and Bhiwadi (Rajasthan).

Administrative measures to improve efficiency and transparency:

The approvals granted by the CDSCO are regularly posted on the websitewww.cdsco.nic.in.

The licences and approvals granted put on display daily on two LCDs forthe information of the general public at FDA Bhawan, Kotla Road, NewDelhi.

File tracking system introduced in the CDSCO headquarters as well as inthe North Zone office of CDSCO

The approval letters in respect of Clinical trials and registration certificateand Import licenses of drugs posted on the website.

Guidance Documents for industry and other stake-holders in respect ofapproval of new drugs including FDCs were posted on website.

Initiated Pre-screening of applications before acceptance for review.

Guidance documents:

In order to streamline the review of the applications for various regulatory approvals

the following guidance documents were prepared and uploaded on CDSCO

websites for general information to the stakeholders

http://www.cdsco.nic.in/






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S. No. Name of Document Date of Posting

on Website

Guidance for Industry

Submission of Clinical Trial Application for

Evaluating Safety and EfficacyRequirements for permission of Drugs Approval

Post approval changes in biological products:Quality safety and Efficacy DocumentsPreparation of the Quality Information for DrugSubmission for Drug Approval:Biotechnological/Biological Products

04.12.2008

1. Guidance document on common submission formatfor registration of medical devices in India

04.08.2010

2. Requirements for conducting Clinical trial(s) ofmedical Devices in India

04.08.2010

3. Guidance document on application for grant oflicence in Form-28 for manufacture of medicaldevices in India under CLAA scheme

12.08.2010

4. Draft guidance for industry on fixed dosecombinations

20.08.2010

5. Guidance document on common submission format

for import licence in Form 10 of medical devices inIndia

25.08.2010

6. Draft Guidance for industry on preparation ofCommon Technical Document (CTD ) for import /manufacture and marketing approval of new drugs forhuman use (New Drug Application – NDA)

28.10.2010

7. Guidance on clinical trial Inspection 01.11.2010

8. Draft guidelines on reporting of serious adverse

events in clinical trials

11.05.2011

9. Guidance document on common submission formatfor issuance of No Objection Certificate for export ofunapproved/approved new drugs/Banned drugs.

15.05.2011

10. Guidance document on grant of licence in Form11(test licence) for the purpose of examinationtesting and analysis as per rule 33 of drugs andcosmetics acts and rules 1945

30.05.2011

11. Guidance document for functions and responsibilitiesof zonal, sub-zonal & port offices of CDSCO

17.06.2011

http://cdsco.nic.in/Guidance%20Document%20on%20Common%20%20%20Submission%20Format%20for%20Registration%20of%20Medical%20Devices%20in%20India.Pdf


http://cdsco.nic.in/Guidance%20document%20on%20application%20for%20grant%20of%20Licence%20in%20Form-28%20for%20manufacture%20of%20Medical%20Devices%20in%20India%20under%20CLAA%20Scheme.PDF



http://cdsco.nic.in/FDC%20Guidelines%20_%20Revised1.pdf



http://cdsco.nic.in/Guidance.PDF















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12. Draft Guidance document on Submission ofapplication for Import and Registration of bulk drugsand finished formulations in India.

20.07.2011

13. Draft Guidelines on approval of clinical trial & newdrugs

23.07.2011

14. Guidelines for I.V fluids distribution, storage andadministration

04.08.2011

Revision of National List of Essential Medicines

The National list of essential medicines (NLEM) is one of the key instruments in

balanced healthcare delivery system of a country. The first National List of Essential

Medicines of India was prepared and released in 1996. This list was subsequently

revised in 2003.

The National list of essential medicines (NLEM) was further revised and

NLEM 2011 was prepared.

Country Wide Survey on Spurious Drugs:

A survey to assess the extent of spurious drugs in the country was conducted in the

year 2009, on the basis of statistical principles provided by Indian Statistical Institute

(ISI), Hyderabad. Under this survey 24,136 samples of 62 brands of drugs belonging

to 9 therapeutic categories of 30 manufacturers from over 100 different Pharmacy

outlets in different regions of the country and located in each stratum viz. metros, big

cities, district, towns and villages were collected. The survey had revealed that the

extent of drugs found spurious was 0.046% only.

Comparison of present study with the study conducted by SEARPharm

Parameter Study conducted by

SEARPharm

Present study

No. of Samples Collected 10,743 24,136

No. of Therapeutic category 12 9

Name of the stratum fromwhere the samples werecollected

Metro Cities (MC)

Big Cities (BC)

District HeadQuarters (DHQ)

Metro Cities (MC)

Big Cities (BC)

District Head Quarters (DHQ)

Towns (T)

Village (Vill)

Number of brands 56 61No. of samples checked 100% by the Study team 100% through respective



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Physically manufacturer (Matching of followingParameters)

Foil matching

Text matter matching

Font size of brand

Brand Symbol

Dimensions of the strip

Description of the product fromthe transparent side of thestrip)

Extent of counterfeit suspects

on the basis of physicalexamination

In the tune of 3.1% 0.046% (11 samples were not accepted

by the manufacturers as theirproducts)

No. of Samples TestedChemically

2,455 (Suspect and genuinesamples are mixed) throughPVT. Laboratories, which isaround 25% of the totalsample collected.

2976 samples (from 24,125unsuspected samples) through Govt. Testing Laboratories which is around12.336% of the total samples collected.

Parameter tested for chemicalanalysis

Identification and Assay Identification and Assay

Failing of Pharmacopoeiastandards in terms of labelclaim on laboratory analysis(Not of Standard Quality)

0.3% {Out of 2,455,08samples do not conform toclaim}

0.101% {Out of 2976 unsuspectedsamples, 03 samples do not conformto claim with respect to Assay (84.8 to89.3% of the claim)}

National Pharmacovigilance Programme

A Pharmacovigilance Programme of India (PVPI) was launched on 14.07.2010 to

capture Adverse Drug Reactions data in Indian populations in a systematic way in

CDSCO. The programme is now coordinated by the Indian Pharmacopeia

Commission, Ghaziabad. Currently, 60 medical colleges are functioning as Adverse

Drug Reaction monitoring centres.

Overseas Inspections

The office of CDSCO has started inspection of Pharmaceutical firms for import

registration of drugs. In May 2011, six bulk drugs manufacturing in China wereinspected out of which registration certificate and import license of one unit was

cancelled. Further, in February 2012, 4 drug manufacturing in China were inspected

as per the provisions.

Strengthening of clinical trials regulations

Various initiatives were taken for strengthening of clinical trial regulation to ensure

the protection rights, safety and well being of Clinical Trial subjects and authenticity

of bio medical data generated. Some of the initiatives taken are as under:



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a. It was made mandatory for registration of clinical trials with the CentralizedClinical Trial Registry of ICMR with effect from 15 th June 2009.

b. Guidelines for conducting Clinical Trials inspections were posted on thewebsite of CDSCO (i.e. ww.cdsco.nic.in).

c. 12 New Drug Advisory Committees (NDAC) were constituted to examinethe applications for permissions for clinical trials and approvals for newdrugs.

d. The Drugs and Cosmetics Rules were further proposed to be amended tomake provisions for regulation of clinical trial. Draft notification specifyingthe requirements and guidelines for registration of Clinical ResearchOrganization (CROs) have already been published on 19.01.11.

Some of the important proposals for the amendments which have already been

approved by DTAB are as under:

Provisions for payment of compensation in case of trial related injury ordeath.

Enhancement of the responsibilities of Ethics Committee, Investigator andSponsor to ensure that financial compensation as well as medical care is providedto the trial subjects who suffer trial related injury or deaths.

Registration of Ethics Committees

Provisions for clinical trial inspections

Creation of Pharmazones:

Initiatives was taken for creation of pharmaceutical zones at Delhi, and other

ports for providing dedicated areas for storage of drugs and sampling of drugs

meant for import or export of drugs. The pharma zone has been setup in Hyderabad

Air port while at Delhi IGI Airport it is in advanced stage.

Introduction of Good Laboratory Practices

The rules relating to Good Laboratory Practices have become operative since 1 st

day of November, 2010.These rules provide for Good housekeeping and safety

provisions for the maintenance of the laboratory. The manufacturers having in-houselaboratories are required to conform to the provisions of the said Schedule.



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Registration of Cosmetics

The Drugs and Cosmetics Rules, 1945 were amended by a Gazette Notification

GSR 426(E) dated 19th May, 2010 for registration of cosmetics imported into thecountry. The registration would become mandatory from 1st October, 2012.

Delegation of powers of CDSCO, HQ to Zonal Offices

of CDSCO:

The following powers were delegated on 1st June 2011 to Zonal offices:

No objection certificates for grant of license to manufacture drugs for thepurpose of examination, test or analysis(Rule 89)

No objection certificate for grant of permission for manufacture for exportonly of unapproved/approved new drugs and drugs banned.

Permit for import of small quantities of drugs for personal use under Form12 B of the Rules.

No objection certificate for grant of permissions for import of dual use items,not for medicinal use.

Manpower in CDSCO (Current position vis-à-vis position in 2008)

STAFF POSITION CDSCO, March, 2012

S.No Name of

the post

No. of

sanctioned

posts as on

April 2008

Status as on April

2008

Posts created

Year 2008 & 2009

No. of

Sanctioned

Posts as on

March 2012

In Position

as on

March

2012

Vacant

Posts as

on March

2012

In Position Vacancies 2008 2009

1 DCG(I) 1 1 0 - - 1 0 1

2 JDC(I) 1 0 1 1 2 - 2

3 DDC(I) 9 1 8 - 10 19 10 9

4. ADC(I) 16 16 0 - 25 41 15 26

5. DI 32 12 20 62 75 169 65 104

6. Asst DI - - - 31 31 - 31*

7. Sr.

Biomedic

al

engineer

- - - 1 1 - 1

8. Biomedic

al

engineer

- - - 1 1 - 1

9. TO 14 5 9 10 - 24 14 10

10. STA 17 13 4 - - 17 9 8

11. T.A. 21 16 5 - - 21 6 15

Total 111 64 47 72 144 327 119 208



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Targets/Roadmap/Capacity Building: 2013-2020

For CDSCO:

Strengthening of CDSCO manpower by creating additional 1195 newposts, including 64 experts and additional 4300 personnel for newlaboratories, mobile drug testing labs, E-governance, training academy

E-Governance System- To increase transparency and credibility. Withthis, all offices of Zonal/Sub-Zonal/Port offices/laboratories of CDSCOand offices of State Drugs Controllers will be interlinked for fastcommunication, IT enabled services, preparation of National Registry,Video Conferencing, archiving of all files etc.

Consumer awareness programs to educated and sensitise consumers,medical care providers etc on drug safety alerts, promotion of genericdrugs, self medication issues, etc

Setup of 8 new Central Drugs Testing Laboratories with a capacity totest around 8000 samples per annum by each laboratory.

Up gradation of existing 6 Central Drugs Laboratories.

Up gradation of existing CDSCO zonal/sub-zonal and Port offices.

Setup of 5 new Central Cosmetics Testing labs, 3 new CentralDiagnostic kit labs and 5 new Central Medical Devices TestingLaboratories.

Setup of 20 mini drug testing labs at port offices of CDSCO to monitorquality of imported and exported drugs.

Purchase of 20 mobile drug testing vans to monitor quality of drugsmoving in the market.

Setup state of art Pharma Research laboratory to carry out sophisticatedanalysis of drugs to detect foreign (contaminants) substances in drugs.

Setup of National Drug Regulators Training Academy to impartcontinuous training to the drug regulators.

Setup of India Country Offices in 5 Countries to inspect foreignmanufacturing facilities and address other regulatory issues.

Effective implementation of Pharmacovigillance Program of India.



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Conduct regular overseas inspections to verify GMP compliance andother statutory requirements.

For State Drugs Regulatory System: Under Centrally

Sponsored Scheme.

Creation of additional 2500 manpower (regulators)

Setup of 20 new State drugs testing laboratories and 2000 additionalmanpower for new labs.

Up gradation of all 26 state drug testing laboratories

Construction/expansion/up gradation of State Drugs Control Offices.